MAUDE Adverse Event Report: SYMATESE EVOLYSSE FORM; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	EVO-FRM-01
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Subcutaneous Nodule (4548)
Date of Event	09/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The healthcare professional reported injecting evolysse form into the lips of a patient.Patient had extreme lip swelling initially.Then on (b)(6) 2025, approximately ten (10) days post injection, patient experienced hard nodules in lips.On (b)(6) 2025, the hcp dissolved the product with two (2) vials of hylenex.The hcp suspected the nodules were infectious in nature and prescribed an unknown antibiotic.The patient experienced a complete resolution of symptoms.
Additional Manufacturer Narrative
This is a known potential adverse event addressed in the product labeling and risk management file.The filler was injected into the patient and is not available for return.The event is a physiological event complication and analysis of the device does not assist in determining a probable cause of the event.The production records for the lot were reviewed, and no deviations were found during production that would relate to the reported event; the device met all specifications.A total of three (3) complaints have been reported for this lot; no adverse trend was identified.The hcp reported the product was stored extreme heat for three (3) days prior to use.We cannot rule out that this may have contributed to the reported event.Product quality cannot be guaranteed when stored outside of labeled environmental conditions.A potential contributory factor may include the off-label use of evolysse form in the lip region.(b)(4).

• Brand Name: EVOLYSSE FORM
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): SYMATESE; zi les troques; chapnost, auvergne-rhone-alpes 69630 ; FR 69630
• Manufacturer (Section G): SYMATESE; zi les troques; chapnost, auvergne-rhone-alpes 69630 ; FR 69630
• Manufacturer Contact: laurence hermitte ; zi les troques; chapnost, auvergne-rhone-alpes 69630 ; FR 69630
• MDR Report Key: 23528177
• Report Number: 3003672980-2025-00167
• Device Sequence Number: 10167535
• Product Code: LMH
• UDI-Device Identifier: 03760172161264
• UDI-Public: (01)03760172161264(17)270228(10)S2250900178
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P240022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: EVO-FRM-01
• Device Lot Number: S2250900178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown